The original NCD, in February 2018, focused on companion diagnostic tumor tissue tests (e.g. the Foundation Medicine F1 test). It gave special coverage benefits to tumor tests that were approved as FDA companion diagnostics.
Stakeholders complained during 2018 and in early 2019 that the NCD inadvertently tended to block coverage of germline NGS tests, since the NCD focused coverage boundaries on "advanced cancer" patients. CMS posted a draft revision of the NCD in October 2019, and the final revision now.
See the full NCD here:
https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=296
CMS also issued a press release, here.
See coverage at Genomeweb here. At MedCity News here. HealthtechDive here. Healthcare Finance News here. Health Payer Intelligence here. Becker's Hospital News, here.
In the press release, CMS Administrator Seema Verma is quoted: “We recognize that cancer patients shoulder a heavy burden, so we’re leaving no stone unturned in supporting women’s health and getting all patients the care they need. NGS testing provides clinically valuable information to guide patients and physicians in developing a personalized treatment plan....Innovative technologies are transforming medicine, and at every turn, President Trump has shown a dogged determination to give Americans access to them”
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Below, I primarily quote the text. For a later blog that dissects some of the quirks and weirdness, here.
I've cut and pasted the pivotal text (the coverage text) below. This is the NEW text, the text that is related to germline sequencing.
A. The Centers for Medicare & Medicaid Services (CMS) has determined that Next Generation Sequencing (NGS) as a diagnostic laboratory test is reasonable and necessary and covered nationally, when performed in a CLIA-certified laboratory, when ordered by a treating physician and when all of the following requirements are met:
- The patient has:
- ovarian or breast cancer; and
- a clinical indication for germline (inherited) testing for hereditary breast or ovarian cancer; and
- a risk factor for germline (inherited) breast or ovarian cancer; and
- not been previously tested with the same germline test using NGS for the same germline genetic content.
- The diagnostic laboratory test using NGS must have all of the following:
- Food and Drug Administration (FDA) approval or clearance; and
- results provided to the treating physician for management of the patient using a report template to specify treatment options.
B. Other
Medicare Administrative Contractors (MACs) may determine coverage of Next Generation Sequencing (NGS) as a diagnostic laboratory test when performed in a CLIA-certified laboratory, when ordered by a treating physician, when results are provided to the treating physician for management of the patient and when the patient has:
- any cancer diagnosis; and
- a clinical indication for germline (inherited) testing of hereditary cancers; and
- a risk factor for germline (inherited) cancer; and
- not been previously tested with the same germline test using NGS for the same germline genetic content.
We are making other technical, clarifying, and conforming changes in Section 90.2 of the National Coverage Determinations Manual. We are clarifying the existing policy related to diagnostic tests for Somatic (Acquired) Cancer.
See Appendix B for the draft manual language.
For ease of the reader, this National Coverage Determination (NCD) is only applicable to diagnostic lab tests using NGS for somatic (acquired) and germline (inherited) cancer.
Medicare Administrative Contractors (MACs) may determine coverage of diagnostic lab tests using NGS for RNA sequencing and protein analysis.
MACs also have discretion to determine coverage of diagnostic lab tests using NGS for any non-cancer (e.g., infectious disease and heart disease) use. These uses are outside the scope of this NCD.
My head is spinning a bit from the fact they refer to "Patients with Somatic (Acquired) and Germline (Inherited) Cancer." Normally you would refer to germline sequencing tests for inherited mutations and somatic sequencing tests for acquired mutations - not "germline and acquired cancers."
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The full NCD coverage section, including both old and new text,
is clipped below (as provided by CMS in its "Appendix B."
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90.2 Next Generation Sequencing (NGS) for Patients with Somatic (Acquired) and Germline (Inherited) Cancer [New title]
A. General
Clinical laboratory diagnostic tests can include tests that, for example, predict the risk associated with one or more genetic variations. In addition, in vitro companion diagnostic laboratory tests provide a report of test results of genetic variations and are essential for the safe and effective use of a corresponding therapeutic product. Next Generation Sequencing (NGS) is one technique that can measure one or more genetic variations as a laboratory diagnostic test, such as when used as a companion in vitro diagnostic test.
This National Coverage Determination (NCD) is only applicable to diagnostic lab tests using NGS for somatic (acquired) and germline (inherited) cancer. Medicare Administrative Contractors (MACs) may determine coverage of diagnostic lab tests using NGS for RNA sequencing and protein analysis. MACs also have discretion to determine coverage of diagnostic lab tests using NGS for any non-cancer (e.g., infectious disease and heart disease) use. These uses are outside the scope of this NCD.
B. Nationally Covered Indications
- Somatic (Acquired) Cancer
Effective for services performed on or after March 16, 2018, the Centers for Medicare & Medicaid Services (CMS) has determined that Next Generation Sequencing (NGS) as a diagnostic laboratory test is reasonable and necessary and covered nationally, when performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory, when ordered by a treating physician, and when all of the following requirements are met:
- Patient has:
- either recurrent, relapsed, refractory, metastatic, or advanced stage III or IV cancer; and
- not been previously tested with the same test using NGS for the same cancer genetic content, and
- decided to seek further cancer treatment (e.g., therapeutic chemotherapy).
- The diagnostic laboratory test using NGS must have:
- Food & Drug Administration (FDA) approval or clearance as a companion in vitro diagnostic; and,
- an FDA-approved or -cleared indication for use in that patient’s cancer; and,
- results provided to the treating physician for management of the patient using a report template to specify treatment options.
- (NEW) Germline (Inherited) Cancer
Effective for services performed on or after [DATE], CMS has determined that NGS as a diagnostic laboratory test is reasonable and necessary and covered nationally for patients with germline (inherited) cancer, when performed in a CLIA-certified laboratory, when ordered by a treating physician and when all of the following requirements are met:
- Patient has:
- ovarian or breast cancer; and,
- a clinical indication for germline (inherited) testing for hereditary breast or ovarian cancer; and,
- a risk factor for germline (inherited) breast or ovarian cancer; and
- not been previously tested with the same germline test using NGS for the same germline genetic content.
- The diagnostic laboratory test using NGS must have all of the following:
- FDA-approval or clearance; and,
- results provided to the treating physician for management of the patient using a report template to specify treatment options.
C. Nationally Non-Covered Indications
- Somatic (Acquired) Cancer
Effective for services performed on or after March 16, 2018, NGS as a diagnostic laboratory test for patients with acquired (somatic) cancer are non-covered if the cancer patient does not meet the criteria noted in section B.1. above.
D. Other
- Somatic (Acquired) Cancer
Effective for services performed on or after March 16, 2018, Medicare Administrative Contractors (MACs) may determine coverage of NGS as a diagnostic laboratory test for patients with advanced cancer only when the test is performed in a CLIA-certified laboratory, when ordered by a treating physician, and when the patient has:
a. either recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer; and,
b. not been previously tested with the same test using NGS for the same cancer genetic content, and
c. decided to seek further cancer treatment (e.g., therapeutic chemotherapy).
b. not been previously tested with the same test using NGS for the same cancer genetic content, and
c. decided to seek further cancer treatment (e.g., therapeutic chemotherapy).
- (NEW) Germline (Inherited) Cancer
Effective for services performed on or after [DATE], MACs may determine coverage of NGS as a diagnostic laboratory test for patients with germline (inherited) cancer only when the test is performed in a CLIA-certified laboratory, when ordered by a treating physician, when results are provided to the treating physician for management of the patient and when the patient has:
- any cancer diagnosis; and,
- a clinical indication for germline (inherited) testing of hereditary cancers; and,
- a risk factor for germline (inherited) cancer; and,
- not been previously tested with the same germline test using NGS for the same germline genetic content.
(This NCD last reviewed XX.)
